In parenteral solution administration it is of course necessary to maintain the highest aseptic standards.
Particularly in the area of total parenteral nutrition, where a patient is completely maintained for significant periods of time by nutrients administered parenterally, there is a significant need for preserving sterility when the various nutrient solutions are mixed for administration. Specifically, when dextrose or other carbohydrate solutions are mixed with amino acid or protein hydrolysate solutions, bacteria growth can be explosively rapid in the resulting mixture. Accordingly, extra care must be taken in such circumstances. Particularly, in the present techniques of use, such solutions are mixed only immediately before use despite their sterile environment, to avoid the risk of the explosive growth of bacteria.
However, it would be desirable to have a system which permits the safe mixing of parenteral solutions such as dextrose or other carbohydrate solutions with an amino acid or protein hydrolysate solution, while permitting the resulting mixture to be stored for a period of days. The hospital administration of such materials would be greatly facilitated by permitting the premixing of the materials.
In the present system, a standard Viaflex.RTM. container, which is a flat, collapsible bag manufactured by Travenol Laboratories, Inc., is initially about half-filled with a parenteral solution such as 50% Dextrose. Protein hydrolysate solution may be administered into the Viaflex bag through the end spike of an administration set which passes through a diaphragm port of the Viaflex bag, which diaphragm port is carried by the peripheral heat seal of the bag.
After the protein hydrolysate is passed through the set into the bag, filling it, the flexible tubing of the set may be conventionally sealed and then cut through the seal to separate the bag, so that the spike penetrating into the port of the Viaflex bag and a sealed section of tubing connected to the spike serves as a seal.
As stated above, such a system is not recommended for storage, but should be infused shortly after mixing.
By this invention, a system is provided in which large volume parenteral solutions and the like may be mixed without a reduction in their shelf life, so that protein hydrolysate and carbohydrates, for example, may be mixed for total parenteral nutrition and then stored for a period of days, awaiting the time of use.
Furthermore, a flexible, collapsible container of this invention is disclosed in which a flexible, tubular boot member of improved design is provided to avoid substantially outward expansion of the boot member as it is collapsed to advance a cannula through a diaphragm, for opening of the container. Thus, the boot member can operate in a crowded area adjacent other ports, since it does not expand into interfering contact with closely adjacent ports.